510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843784Substantially Equivalent

Vitajet Jet Insulin Injection Device

Vitajet Industriae Comercioltda., Rio De Janeiro Brazil, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843784 is the FDA 510(k) clearance record for VITAJET JET INSULIN INJECTION DEVICE, a class II device, cleared for Vitajet Industriae Comercioltda. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 2 510(k) clearances for Vitajet Industriae Comercioltda., from to . As of , FDA records show no recalls naming K843784.

Clearance record

Decision date
Received
(37 days to decision)
Product code
KZE Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
Device class
Class II
Review panel
General Hospital
Applicant
Vitajet Industriae Comercioltda. 114 -, Rio De Janeiro Brazil, BR
Third party review
No

Clearances, product code KZE

Trailing 12 months

FDA records hold no clearances under product code KZE in the trailing twelve months.

FDA records show no clearances under product code KZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260